S. 142, Preserve Access to Affordable Generics and Biosimilars Act
As reported by the Senate Committee on the Judiciary on March 1, 2023
By Fiscal Year, Millions of Dollars
2024
2024-2029
2024-2034
Direct Spending (Outlays)
-1
-447
-1,280
Revenues
0
135
366
Spending Subject to Appropriation (Outlays)
*
5
not estimated
Increases net direct spending in any of the four consecutive 10-year periods beginning in 2035?
No
Statutory pay-as-you-go procedures apply?
Yes
Mandate Effects
Increases on-budget deficits in any of the four consecutive 10-year periods beginning in 2035?
No
Contains intergovernmental mandate?
No
Contains private-sector mandate?
Yes, Over Threshold
* = between zero and $500,000.
The bill would
Prohibit certain anticompetitive settlement agreements that resolve patent infringement claims against manufacturers of generic drugs or biosimilar biological products
Create a framework under which the Federal Trade Commission (FTC) could block prohibited settlement agreements and seek penalties from parties to those agreements
Require parties to certain settlement agreements arising from proceedings conducted by the Patent Trial and Appeal Board (PTAB) to report them to the FTC and the Department of Justice
Impose private-sector mandates by enhancing the FTC’s authority to restrict certain agreements and by requiring pharmaceutical manufacturers to notify the FTC of agreements that settle PTAB proceedings
Estimated budgetary effects would mainly stem from
Generic drugs or biosimilar biological products entering the market earlier than they would under current law, resulting in lower federal spending for prescription drugs and health insurance subsidies
Areas of significant uncertainty include
Predicting the extent to which manufacturers of drugs or biosimilar biological products would continue to enter into anticompetitive settlement agreements
Determining the number of settlement agreements permitted under current law that would be prohibited under the bill
Estimating the total sales of drugs and biological products whose manufacturers would enter into prohibited settlement agreements regarding those drugs or biological products under current law but not under the bill
